Cleared Traditional

K854316 - FASTENS(TM)

K854316 is an FDA 510(k) clearance for FASTENS(TM), manufactured by Medical Devices, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K854316 · Medical Devices, Inc. · Neurology device
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Feb 1986
Decision
123d
Days
Class 2
Risk

K854316 is an FDA 510(k) clearance for the FASTENS(TM). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medical Devices, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 28, 1986 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Devices, Inc. devices

FDA 510(k) Submission Details - K854316

510(k) Number K854316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date February 28, 1986
Days to Decision 123 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 148d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 140
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K854316.
ULTRAPAC II SD (TM)
K862337 · Medical Devices, Inc. · Aug 1986
EMPI MODEL GLS 450, TENS
K861830 · Empi · Jul 1986
EMPI MODEL 720 NMS, TENS
K861451 · Empi · Jul 1986
VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &
K853992 · Valley Forge Scientific Corp. · Feb 1986
MINIPAC PERSONAL TOUCH (TM)
K854761 · Medical Devices, Inc. · Feb 1986
MINIPAC (TM)
K854317 · Medical Devices, Inc. · Jan 1986